Description
Sorafenib Tablets (200 mg)
Healthy Inc is a specialized global supplier and exporter of advanced targeted oncology, antineoplastic, and critical-care therapeutics. We provide ultra-high-purity, kinetically stabilized Sorafenib Tosylate Film-Coated Tablets (200 mg), manufactured in WHO–GMP certified, strictly dedicated negative-pressure hazardous oncology facilities. This “Multi-Kinase Inhibitor” is a high-value, critical export to comprehensive cancer centers, state oncology boards, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-prolonging standard of care for inoperable liver, kidney, and thyroid carcinomas.
Product Overview
This formulation contains Sorafenib (as Sorafenib Tosylate), an incredibly advanced targeted therapy that attacks cancer on two completely different physiological fronts simultaneously, drastically extending progression-free survival in patients with aggressive solid tumors.
The “Anti-Angiogenesis & Tumor Starvation” Specialist:
- Mechanism 1 (Halting Tumor Proliferation – RAF Kinase Blockade): Inside the cancer cell, signals are sent through the RAF/MEK/ERK pathway telling the cell to constantly divide and multiply. Sorafenib aggressively binds to and blocks mutant and wild-type RAF kinases. By cutting this communication wire, it forcefully arrests the tumor cell cycle, stopping the cancer from growing.
- Mechanism 2 (Choking the Blood Supply – VEGF/PDGF Blockade): Tumors cannot grow larger than a few millimeters unless they build their own blood vessels to steal nutrients from the body (a process called angiogenesis). Sorafenib vigorously inhibits the Vascular Endothelial Growth Factor (VEGFR) and Platelet-Derived Growth Factor (PDGFR) receptors on the cell surface. This literally starves the tumor to death by preventing it from building a blood supply.
- The Oral Oncology Advantage: Instead of patients spending hours attached to IV infusions in a hospital, Sorafenib delivers elite-level, systemic cancer eradication in a highly convenient, twice-daily oral tablet, drastically improving the patient’s quality of life during palliative and life-extending care.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated Tablet, packed in highly secure, child-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles to ensure the absolute stability of the tosylate salt formulation.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Sorafenib Tosylate INN/Ph.Eur. | 200 mg (Equivalent to Sorafenib free base) | Global Standard: Base titration unit for the standard 800 mg daily oncology regimen. |
| Excipients | Croscarmellose Sodium / Microcrystalline Cellulose / Hypromellose / Magnesium Stearate | Superdisintegrant / Diluent / Film-Coating (Engineered for strict gastric dissolution and reliable systemic bioavailability) |
*Pack Sizes: 120 Tablets per HDPE Bottle or 4×30 Alu-Alu Blisters (Optimized specifically for exact 30-day oncology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Oncology Procurement Boards, and Cancer Center Networks.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antineoplastic/Oncology) |
| CAS Number | 284461-73-0 (Sorafenib) / 475207-59-1 (Sorafenib Tosylate) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Child-Resistant Alu-Alu Blisters or HDPE Bottles. Provides a sturdy, tamper-evident barrier necessary for protecting clinical handlers from hazardous cytotoxic exposure. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified oncology units.
- Hazardous Cytotoxic (OEB) Containment: Sorafenib is a highly potent antineoplastic agent. Our manufacturing is executed within strictly isolated, completely dedicated Oncology blocks operating under severe negative pressure with multi-stage HEPA filtration. Powders and granulation are handled inside closed-loop barrier isolators (glove boxes) to guarantee absolute operator safety and zero cross-contamination with non-oncology generics.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of advanced, aggressive solid tumors:
- Hepatocellular Carcinoma (HCC): Treatment of patients with unresectable (inoperable) liver cancer.
- Renal Cell Carcinoma (RCC): Treatment of patients with advanced kidney cancer.
- Differentiated Thyroid Carcinoma (DTC): Treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.
Dosage & Administration
Recommended Dosage (Strictly as per Board-Certified Medical Oncologist):
- Standard Adult Dosing: The recommended daily dose is 400 mg (two 200 mg tablets) taken twice daily without food (for a total daily dose of 800 mg).
- Administration (THE DIETARY FAT RULE): Tablets must be swallowed whole with water. They MUST be taken on an empty stomach (at least 1 hour before or 2 hours after a meal). If taken with a moderate or high-fat meal, the absorption (bioavailability) of the cancer drug plummets by nearly 30%, severely risking therapeutic failure.
- Dose Modification: Treatment is continued until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. Dose reductions to 400 mg once daily are common if severe skin reactions occur.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Hand-Foot Skin Reaction (Palmar-Plantar Erythrodysesthesia): A hallmark, severe side effect of Sorafenib is blistering, severe pain, and peeling of the palms of the hands and soles of the feet. This often requires temporary interruption of therapy or dose reduction to prevent permanent tissue damage.
- Cardiovascular Events & Hypertension: Sorafenib vigorously increases blood pressure (often within the first few weeks of therapy) and increases the risk of cardiac ischemia or myocardial infarction (heart attack). Blood pressure must be monitored strictly every week during early therapy.
- Severe Hemorrhage: Because it interferes with blood vessel formation, it dramatically increases the risk of severe, sometimes fatal bleeding (especially gastrointestinal or respiratory tract hemorrhage).
- Gastrointestinal Perforation: A rare but fatal risk of the stomach or intestines tearing open.
- Teratogenicity (BLACK BOX EQUIVALENT): Absolutely contraindicated in pregnancy (Category D). It will cause catastrophic fetal malformations and fetal death. Strict contraception is mandatory.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Oncology and Cytotoxic Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government cancer programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.










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